BEUDAMED
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    X-PORTE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707011019·CALIBRA 1ST MOL BANDS W/G8025-02 n.UR 17

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158219250·UTERINE DILATOR HEGAR DOUBLE ENDED 17/18MMØ

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694016698·MFx Angulated Locking Angle Plate, 2 x 2 Hole

    SC2000 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BAHA DIVINO

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Magna-FX®

    FDA UDI
    Zimmer, Inc.·00889024024793·

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code OYC·January 12, 2017

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code MDS·January 17, 2017

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·June 28, 2011

    TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·October 2, 2018

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·June 24, 2025

    Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU. Microlab AT+ and Microlab AT+2, part numbers 142000, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036

    FDA Recall
    Terminated ·Hamilton Co·Product code JTC·December 13, 2005

    Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.

    FDA Recall
    Terminated ·Kalila Medical·Product code DYB·December 14, 2017

    Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.

    FDA Recall
    Terminated ·Kalila Medical·Product code DYB·December 14, 2017

    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·August 23, 2017

    Dr Mullins Kit, kit number PSS1861(A convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·March 14, 2018